Q Results Conference Call

Transcription

1 August 2, 2018 Q Results Conference Call MorphoSys AG

2 Today on the Call Dr. Simon Moroney Jens Holstein Chief Executive Officer Chief Financial Officer 2

3 This presentation includes forward-looking statements. This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including its financial guidance for 2018, the commencement, timing and results of clinical trials and release of clinical data both in respect of its proprietary product candidates and of product candidates of its collaborators, the development of commercial capabilities, in particular with respect to MOR208, and the transition of MorphoSys to a fully integrated biopharmaceutical company, the expected time of launch of MOR208, interaction with regulators, including the potential approval of MorphoSys s current or future drug candidates, including discussions with the FDA regarding the potential approval to market MOR208, and expected royalty and milestone payments in connection with MorphoSys s collaborations. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys s expectations regarding its 2018 results of operations may be incorrect, MorphoSys s expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that MorphoSys may fail to obtain regulatory approval for MOR208 and that data from MorphoSys s ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), MorphoSys s reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys s Registration Statement on Form F-1 and other filings with the US Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for guselkumab/tremfya ). 3

4 Agenda 1. Operational Review Q & Outlook Financials Q & Guidance Q&A Session 4

5 Operational Review Q and Outlook

6 Proprietary Portfolio MOR208 Investigational Fc-enhanced Antibody Directed Against CD19 Current clinical development L-MIND and B-MIND trials in relapsed or refractory DLBCL (r/r DLBCL) COSMOS trial in r/r CLL/SLL after discontinuation of ibrutinib therapy L-MIND: Current Activities Interactions with FDA under breakthrough therapy designation ongoing Presentation of updated clinical data from L-MIND trial at ASH 2018 expected, final data expected next year COSMOS data in CLL/SLL presented at EHA 2018 First data from cohort A (MOR208 + idelalisib) presented at EHA conference in June 2018 Presentation of data from cohort B with MOR208 + venetoclax expected for end of 2018 Build-up of commercial capabilities in the U.S. / future activities Jennifer Herron to head newly founded MorphoSys US Inc. and build commercial capabilities Evaluation of development options in other lines of DLBCL and in other B cell malignancies ongoing 6

7 Proprietary Portfolio MOR202 Investigational Antibody Targeting CD38 Multiple Myeloma (MM) Phase 1/2a study in r/r MM patients fully recruited Advanced interim data presented at EHA 2018, final data by end of the year expected MorphoSys has decided not to continue development of MOR202 in MM beyond completion of the current phase 1/2a study MorphoSys will continue to support its partner I-Mab s development of MOR202 for the greater Chinese market as planned Other indications Following the discontinuation of a clinical study by Janssen of the CD38 antibody daratumumab in combination with a checkpoint inhibitor, MorphoSys has decided not to continue activities in NSCLC for the time being Evaluation of development in other indications ongoing r/r, relapsed or refractory; NSCLC, non-small cell lung cancer 7

8 Proprietary Portfolio MOR106 Investigational Antibody Directed Against IL-17C The product candidate Ylanthia antibody targeting IL-17C jointly discovered and developed with Galapagos Partnering Deal with Novartis signed July 19, 2018* Worldwide, exclusive agreement with Novartis for development and commercialization of MOR106 expected to accelerate and broaden MOR106 development Continuation of Phase 2 trial IGUANA and start of planned phase 1 study with subcutaneous formulation of MOR106 MorphoSys and Galapagos to engage in additional studies in atopic dermatitis Up-front payment of EUR 95 million (USD 111 million**) Frontloaded milestone package of up to approximately EUR 850 million (USD 1 billion**) Tiered double-digit royalties (low teens to low twenties) on net commercial sales MorphoSys and Galapagos to share all payments equally Novartis to fund all future research, development, manufacturing, commercialization costs for MOR106 *Subject to U.S. anti-trust clearance **Based on exchange rate: 1 EUR = USD (as of July 18, 2018 ) 8

9 Partnered Discovery Programs Highlights More than 100 Programs in R&D, thereof 24 in Clinical Development Tremfya Janssen s anti-il-23 antibody Ongoing phase 3 trials in psoriasis and psoriatic arthritis Phase 2/3 pivotal GALAXI program in Crohn s disease started in July 2018 Primary completion of several phase 3 studies in psoriasis scheduled for 2018, thereof head-tohead comparison with Cosentyx Gantenerumab Roche s antibody to treat Alzheimer s disease New phase 3 studies (GRADUATE-1 and GRADUATE-2) started in June in patients with prodromal and mild Alzheimer s disease Trials assesss optimized gantenerumab dosing scheme BAY New Conjugate by Bayer Against Mesothelin Thorium-227 radiolabeled antibody conjugate directed against mesothelin Phase 1 clinical trial started in June (first-inhuman) to evaluate safety, tolerability, pharmacokinetics and activity of the compound in patients with mesothelin-expressing tumors Cosentyx is a registered trademark of Novartis AG 9

10 Our Clinical Pipeline (July 25, 2018) 29 Product Candidates in Clinical Development, One Product Launched Program Partner Target Disease area Phase 1 Phase 2 Phase 3 Launched Tremfya (Guselkumab)* Janssen IL-23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer s disease MOR208 - CD19 Hematological malignancies 2 Anetumab Ravtansine (BAY ) Bayer Mesothelin (ADC) Solid tumors BHQ880 Novartis DKK-1 Multiple myeloma Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases CNTO6785 Janssen - Inflammation Ianalumab (VAY736) Novartis BAFF-R Inflammation MOR103/GSK ** GSK GM-CSF Inflammation MOR106 Novartis/Galapagos IL-17C Inflammation 13 MOR202 I-Mab Biopharma*** CD38 Multiple myeloma NOV-12 (MAA868) Novartis Factor XI Prevention of thrombosis Setrusumab (BPS804) Mereo/Novartis Sclerostin Brittle bone syndrome Tesidolumab (LFG316) Novartis C5 Eye diseases Utomilumab (PF ) Pfizer 4-1BB Cancer Xentuzumab (BI ) BI IGF-1 Solid tumors BAY Bayer TFPI Hemophilia BAY Bayer Mesothelin Cancer Elgemtumab (LJM716) Novartis HER3 Cancer MOR107 (LP2-3)**** - AT2-R Not disclosed NOV 7 (CLG561) Novartis - Eye diseases NOV 8 Novartis - Inflammation NOV-9 (LKA651) Novartis - Diabetic eye diseases 13 NOV-10 (PCA062) Novartis - Cancer NOV-11 Novartis - Blood disorders NOV-13 (HKT288) Novartis - Cancer NOV-14 Novartis - Asthma PRV-300 (CNTO3157) ProventionBio TLR-3 Inflammation Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors * We still consider Tremfya a phase 3 compound due to ongoing studies in various indications. Partnered Discovery Programs ** MOR103/GSK is fully outlicensed to GSK. Proprietary Development Programs *** For development in the Greater China market (China, Hong Kong, Taiwan, Macau). **** A phase 1 study in healthy volunteers was completed. MOR107 is currently in preclinical investigation with a focus on oncology indications. 10

11 Financials Q2 & Q1-Q Guidance

12 Income Statement* Q In million Q Q Δ Revenues (31%) Research and Development Expenses % Selling Expenses % General and Administrative Expenses % Total Operating Expenses % Other Income / Expenses % EBIT (24.1) (15.4) (56%) Finance Income % Finance Expenses (0.2) (0.3) (33%) Impairment Losses on Financial Assets** (0.6) 0.0 >(100%) Income Tax (Benefit/Expenses) 1.3 (0.4) >100% Consolidated Net Loss (23.5) (16.1) (46%) Earnings per Share (in ) (0.76) (0.56) (36%) * Differences due to rounding. ** New item line due to application of IFRS 9 Financial Instruments since January 1, 2018, for expected twelve-months loss for financial instruments. 12

13 Segment Reporting Q Proprietary Development in million Partnered Discovery in million Revenues R&D EBIT Revenues R&D EBIT

14 Balance Sheet* (June 30, 2018) In million June 30, 2018 Dec 31, 2017 Assets Cash and Cash Equivalents Available-for-sale Financial Assets** Financial Assets classified as Loans & Receivables** Financial Assets at Fair Value through Profit or Loss** Other Financial Assets at Amortized Cost Other Financial Assets at Amortized Cost, Net of current portion** Other Current Assets Total Current Assets Other Non-current Assets Total Non-current Assets Total Assets Liabilities & Stockholders Equity Total Current Liabilities Total Non-current Liabilities Total Stockholders Equity Total Liabilities & Stockholders Equity * Differences due to rounding. ** New classifications for financial instruments due to application of IFRS 9 Financial Instruments since January 1,

15 Half Year 2018 Key Financials* (Q1-Q2 2018) In million Q1-Q Q1-Q Δ Revenues (54%) Research and Development Expenses (5%) Selling % General and Administrative Expenses % Total Operating Expenses % EBIT (43.2) (30.3) (43%) Consolidated Net Profit/(Loss) (43.0) (31.1) (38%) Diluted Net Profit/(Loss) per Share in (1.38) (1.08) (28%) * Differences due to rounding 15

16 Financial Guidance 2018 Increased Guidance Following MOR106 Deal with Novartis* In million Q1-Q Q1-Q Updated Guidance 2018 Group Revenues to 72** Proprietary R&D Expenses (incl. Technology Development) to 97 EBIT (30.3) (43.2) (55) to (65) *Subject to U.S. antitrust clearance; **Revenues are expected to include royalty income from Tremfya ranging from million on constant USD currency. 16

17 Q&A Session 17

18 Thank You Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been approved by the FDA or other ex-us regulatory agencies. HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia, 100 billion high potentials, Slonomics, Lanthio Pharma and LanthioPep are registered trademarks of the MorphoSys Group. Tremfya is a trademark of Janssen Biotech, Inc.